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Clinical Consultants | Expanding Clinical Care
by Margaret Blaetz, CLC, MLT (AMT), MLT, MCM (ASCP),
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The clinical consultant in the laboratory provides a valuable resource in clinical care. However, you will rarely, if ever, see a job advertisement for this position. From a human resources perspective, most clinical consultants are nurses or other allied health professionals who work with vendor support personnel in clinical and non-clinical settings. Often, a clinical consultant assists with work flow analysis and functionality of products or software.

In the clinical laboratory, the Center for Medicare and Medicaid Services (CMS) defines the role of clinical consultant, with educational requirements and responsibilities, in Title 42 of the Code of Federal Regulations (CFR). The clinical consultant provides consultation regarding the appropriateness of the testing ordered and interpretation of test results. The clinical consultant must be qualified to render opinions concerning the diagnosis, treatment and management of patient care. To be qualified as a clinical consultant, the individual must either be qualified as a laboratory director or be a licensed as a Medical Doctor or Doctor of Osteopathic Medicine in the state where employed.

To understand the role and responsibilities of the clinical consultant (CC), it helps to understand the CMS structure for laboratory management. The hierarchy begins with the laboratory director (LD). The LD is responsible for the overall operation and administration of the Laboratory.1 The laboratory director may choose to delegate responsibilities to one or more individuals in the laboratory. When a task has been delegated, the laboratory director remains responsible for ensuring that all duties are properly performed.

The laboratory director, if qualified, may perform the duties of the clinical consultant (CC). The LD may also delegate those responsibilities to one or more qualified individuals. In a laboratory where the LD is not the only employed pathologist, often the responsibilities of clinical consultant will be delegated to one or more of the other pathologists.

A clinical consultant is not required to be onsite during all hours of laboratory testing. However, the CC must be available to provide consultation to customers of the laboratory. The CC must be able to consult on matters related to the quality of the test results reported and their interpretation concerning specific medical conditions.

A clinical consultant may be contacted by a physician if additional information regarding a patient’s test orders, test results or treatment options is needed. At other times, a clinical consultant may be responsible to review patient tests and patient treatments on a routine basis and connect with the patient’s physician proactively.

In many larger laboratories, the CC is often a staff pathologist who has advanced education and training in a particular subspecialty. Looking at some of the responsibilities for clinical consultants, it is easy to see why a staff pathologist is a reasonable and suitable choice for clinical consultant. The volume and scope of work performed by clinical consultants would be overwhelming for a laboratory director to handle without delegation.

Some pathologists chose to continue their education in a sponsored fellowship program. Board-eligible and board-certified pathologists may choose subspecialties such as Cytopathology, Dermatopathology, Hematopathology, Medical Microbiology, Neuropathology, Surgical Pathology and Transfusion

Medicine. When the need for a consultation arises, having a clinical consultant with this specialized training provides for the best patient outcome.

Cytopathology and Surgical Pathology

In the histology laboratory, the pathologist reads the slides of biopsies and cell block. In cytology, the pathologist also provides “over-reads” of gyn and non-gyn fluids and pap smears after they are screened by an imaging system or a cytotechnologist. After reviewing the patient’s clinical history and comparing that to the slide read, the pathologist renders a diagnosis. When a request for consultation is received, putting the requestor in touch with the reading pathologist is the most direct route for communication.


Hematological pathology, or hematopathology, is a subspecialty that studies diseases of the blood. These physicians are experts in diagnosing leukemia, lymphoma, anemia, hemophilia and many other blood-borne diseases. The hematopathologist is often called in for clinical consult based on a blood test performed as part of a routine screen. If the technologist reading the slide sees something out of the ordinary, they will contact the hematopathologist for a consult. If the slide shows cells which are malignant, the hematopathologist will analyze it to determine what kind of disease the patient has.

Once the initial diagnosis is made, the clinician is contacted, and the hematopatholgoist, serving as a clinical consultant, will review additional tests needed as well as direction for treatment.3 The hematopatholgist has become a vital member of the patient’s clinical care team.

Transfusion Medicine

Transfusion medicine is a subspecialty that focuses on providing blood and its components to patients. A pathologist with this specialty makes a great clinical consultant for the blood bank. Rather than wait for a consultation request, this CC often begins the day with a review of the previous days blood transfusions to see if there were any adverse reactions. This is done early in the day since the priority is to ensure patient safety.

If there is a transfusion concern, the CC will ensure the clinical team is aware and will launch any necessary investigation. Some transfusion reactions can be mild, such as itching and hives. Rarely, there are more life-threatening complications. In this case, the transfusion medicine clinical consultant works closely with the clinical team to ensure the patient receives any supportive care required.

Staff pathologists with specialty training are not automatically clinical consultants. Under regulations of CMS, for a pathologist to be considered a clinical consultant, the laboratory director must specify, in writing, the responsibilities and duties of each individual clinical consultant. This designation must be recorded on CMS-209, Laboratory Personnel Report, retained in the personnel files and submitted to CMS upon request.

When searching the help wanted advertisements, you probably won’t see a posting for a clinical consultant in the laboratory. However, there is no denying the value individuals in these roles bring to patient care on a daily basis.

1. Code of Federal Regulations, Title 42 – Public Health Chapter IV – Centers for Medicare and Medicaid Services, Department of Health and Human Services, Subchapter G – Standards and certification, Part 493 – Laboratory requirements

2. Hematological Pathologist What They Do. College Foundation of North Carolina; Copyright © 2001- 2019 College Foundation, Inc.

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